Wire introduction device for introducing a guide wire

ABSTRACT

A deep vein intravenous introducer has a wheel located toward the front end of the device that can be rotated by the index finger of the user. After placement of the needle in the lumen of the vessel, the user rotates the wheel, which advances the wire guide through the center of the needle and into the patient. Once the guide wire is advanced into the vessel lumen the catheter can be advanced over the guide wire with a hub or finger tab on the catheter close to the index finger. The operation can be performed by one hand without moving the hand from its initial position. The user can then simultaneously use the other hand to operate an ultrasound detection device during insertion without the assistance of another person. A catheter is provided that can be visualized by ultrasound to enable confirmation of correct placement in a vessel.

RELATED APPLICATIONS

The present application is a National Phase of PCT ApplicationPCT/US2014/018931 filed Feb. 27, 2014, which claims the benefit of U.S.Provisional Application No. 61/770,052, filed Feb. 27, 2013. The entiredisclosures of those applications are hereby incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to a system, device and method for theintroduction of catheters and more particularly to introduction devicesfor the introduction of catheters into small diameter blood vessels,deep vessels, central veins, arteries, and those visualized byultrasound.

Background of the Related Art

Catheter introduction sets are generally known. For instance, U.S. Pat.No. 4,417,886 discloses a catheter introduction set having a needle,catheter, wire guide and wire guide feed device in which when the needleis positioned into a lumen of a blood vessel, a wire guide is firstinserted into the vessel and the catheter is fed over the wire guidefrom the use of a radially extended handle into the lumen. Thisarrangement is similarly disclosed in U.S. Pat. No. 4,772,264 with theaddition of a retaining finger for stabilization of the catheter on theskin.

However, these catheter introduction sets require the user to use twohands to operate the device. One hand is needed to insert the needle andcatheter, and a second hand to feed the guide wire. This means that onehand has to be taken off the ultrasound probe to feed the guide wire.Consequently, a single user cannot visualize the guide wire directlywhile threading the vessel, which increases the possibility ofmisplacement of the guide wire.

Catheters, both central and peripheral, are not designed to bevisualized under ultrasound and correct placement is essential forproper medication administration. A catheter can be placed into a vesselwith an introducer needle with or without a guide wire. The guide wireand the introducer needle can be visualized under ultrasound, but thecatheter itself cannot be visualized. Because the catheter cannot bevisualized, sometimes catheters are placed incorrectly. Examples ofincorrect catheter placement include: in an artery instead of a vein, ina vein instead of an artery, and in neither a vein nor an artery.Arteries flow next to veins and can be easily catheterized accidentallywhen aiming for a vein. Accidental placement of a catheter in an arteryinstead of a vein can lead to destruction of tissues receiving bloodfrom that artery due to application of medications that damage arteriesand are intended only for use in veins.

While placing an ultrasound guided IV catheter there are two directionalvariables the health care professional has to deal with: longitudinaland vertical. Without the use of a directional marker the physician canbecome disoriented to the longitudinal direction. There is a simplemethod to alleviate this complication by using a directional marker toorient the longitudinal direction of the catheter to the vessel,eliminating this variable and simplifying the ultrasound guidancetechnique. Two temporary points can be marked on the surface of the skinone at the point of planned initial entry of the catheter over thevessel and another small distance distal to this point. The ultrasoundcan be used to follow the vessel allowing the clinician to mark thesetwo points above the vessel on the skin. However, currently availablecatheter introduction sets do not incorporate a means to makedirectional markings on the skin.

Stable position of the body part to be catheterized is essential forboth placement of the catheter and comfort of the patient. Catheterintroduction kits are available manufactured by Arrow International forthe radial artery. These kits include a case that both holds the kitcontents and provides means to stabilize the wrist for the catheterinsertion in the artery of the wrist. Currently there are no kitsavailable for catheter introduction in the anti-cubital veins of theupper arm. Because no such kits are available, practitioners do not havereadily available means to stabilize the arm for catheterization.Likewise, additional body parts that are catheterized besides the arm,also do not have kits available that provide body part stabilizingmeans.

Ultrasound guided vascular access and other procedures must be done inan expedited fashion for medical purposes. Often the speed of vascularaccess can be a matter of life or death. This procedure is invasive,meaning that there is the chance of bacteria being introduced from theskin into the vessel, which is why the procedure must be performed understerile conditions. Ultrasound probes used repeatedly have a propensityto be contaminated. For this reason sterile probe covers are used toprevent infection. Current probe covers for probes used in ultrasoundguided vascular access are large, bulky and time consuming to put on.These probe covers are very long in order to cover not only thetransducer end of the probe, but also much of the cord.

A fast time to catheter placement is essential in the health caresetting for the administration of medications especially in sickpatients, and patients in pain, who have rapidly spreading medicalconditions. When placing an ultrasound guided IV having all the suppliesin one place is essential for placement to be time efficient in theapplication of medicine or performing blood draws. However, thenecessary equipment is often scattered throughout the department or notavailable in the department, making the procedure even more difficult orimpossible to perform. Oftentimes medical professionals resort to usingsurgical rectal lubrication and attempt to use alcohol swabs on dirtyultrasound probes instead of a sterile sheath.

Ultrasound guided catheters are more often in deeper vessels. This isbecause vessels closer to the surface are more easily visualized leadingto greater success with the conventional technique. With the deep andsmall nature of the vessels used in the ultrasound guided IV cathetertechnique it can take more time and attention to place these catheters.More of the catheter is in the soft tissue between the skin surface andthe deep vessel, which means that the deeper vessel has less of thecatheter within its lumen. A slight slip of the catheter can causedisplacement of the catheter from the lumen. In addition, sterilelubrication used for the ultrasound makes it difficult for tape andtegaderm to adhere to the skin. All of these factors make it difficultand essential to secure an ultrasound guided IV catheter.

The placement of an ultrasound guided IV catheter is often painful tothe patient. The use of an anesthetic at the skin surface can makecatheter placement much more comfortable for the patient. The placing ofa catheter via ultrasound usually uses a large bore catheter, 18 gaugeor larger. The large gauge is necessary for the rapid transfusion ofmedicines, fluids and IV contrast, and this can be quite painful,especially because the placement of ultrasound guided IV cathetersusually takes longer than the conventional method with a sharp needlebeing slowly manipulated beneath the skin. The use of local anestheticat the site of entry can alleviate this pain.

Ultrasound guided catheter introduction kits are currently available forcentral venous access, but no kits are available for ultrasound guidedperipheral venous access.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the invention to provide aneedle/catheter introduction apparatus that can be operated with onehand. It is a further object to provide an introduction apparatus thatis reliable and easy to use. It is a further object of the invention toprovide a catheter that can be visualized with ultrasound. It is yetanother object of the invention to provide a probe cover that is easy touse, reliable, and sterile. It is still a further object of theinvention to provide an assembly or kit with components needed forultrasound guided catheter introduction to peripheral veins or arteries.

A needle/catheter introducer is provided that can be operated by onehand. The introducer has a wheel located toward the front end of thedevice that is rotated by the index finger of the user. After placementof the needle in the lumen of the vessel, the user rotates the wheel,which advances the wire guide through the center of the needle and intothe patient. Once the guide wire is advanced into the vessel lumen thecatheter can be advanced over the guide wire with a hub or finger tab onthe catheter close to the index finger. The introducer fits in the palmof the user's hand and the wheel can be operated by the user's indexfinger. Because the actions needed to advance the guide wire and advancethe catheter can both be comfortably performed by one hand withoutmoving the hand from its initial position, the catheter introducer iseasy to use and allows the user to also operate an ultrasound detectiondevice during insertion without the assistance of another person.

In addition, a catheter is provided that is comprised of materials thatmake the catheter capable of being visualized by ultrasound to enableconfirmation of correct placement in a vessel.

In addition, a probe cover is provided that is pre-sterilized andpackaged in a cardboard with the top sides of the cover folded down overthe cardboard. The cover is placed over the probe end, the sides of thecover are folded up, and the cardboard is removed. The sterile probecover can be quickly and efficiently placed over the ultrasound'stransducer end.

Still further, the invention includes a kit having components needed forultrasound guided catheter introduction to peripheral veins or arteries.The kit has a sterile package with an ergonomic shape that can be usedto stabilize the arm. The needle cover, in addition to protecting theneedle, has a tip which can mark the skin to provide a directionalmarker. This allows the needle to be aligned to the direction of thevessel. The catheter introduction set allows a catheter tube to beintroduced into blood vessels such as veins and arteries while keepingthe ultrasound probe cover sterile. The introducer assembly is containedin a sterile package, which is designed to be converted into anergonomic arm stand for assisting in stabilizing the arm while placingthe catheter. The sterile package can also contain the sterile probecover. The introducer assembly is removed as an entire unit includingneedle, catheter, wire guide, rotational wire guide feed device, needlecover with directional guide. The sterile probe cover is placed on thetransducer end of the ultrasound probe. Other items in the kit that onemight need to locate separately (outside of peripheral kits) to performultrasound guided catheter insertion on peripheral veins or arteriesinclude: lidocaine or other anesthetic, sterile gel (for ultrasoundtransduction), ultrasound probe cover for sterile patient contact, tworubber bands to secure the ultrasound probe cover, suture material tostabilize the catheter on the arm.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of the introducer in accordance with thepreferred embodiment of the invention;

FIG. 2 is a side cross-sectional view of the introducer of FIG. 1;

FIG. 3 is an exploded view of the wheel apparatus of FIG. 2;

FIG. 4 is a side view of the wire connector used to couple the drivewire to the guide wire in FIG. 1;

FIG. 5 is a side cross-sectional view of the introducer just prior to aneedle being placed on the introducer;

FIG. 6 is a side cross-sectional view of the introducer coupled with theneedle;

FIG. 7 is a side cross-sectional view of the introducer with the guidewire extended;

FIG. 8 shows the hub extended forward on the guide wire;

FIG. 9 shows the hub and catheter that remains in a patient's bodyfollowing removal of the introducer and introducer needle;

FIG. 10A is an alternative embodiment of the introducer;

FIG. 10B is a perspective view of the wheel assembly in accordance withan alternative embodiment of the invention;

FIG. 11A is a perspective view of the introducer device having needlehandles and hub handles with the two-wheel assembly of FIG. 10B;

FIG. 11B is a perspective view of the introducer device of FIG. 11Ahaving a needle cover;

FIG. 11C is a detailed view of the needle cover tip having projections;

FIG. 12 is a graph showing UV detectable materials;

FIG. 13 is a perspective view of a probe cover assembly prior to beingapplied to a probe in accordance with another embodiment of theinvention;

FIG. 14 shows the cover assembly of FIG. 13 fitted to a probe;

FIG. 15 shows the container removed from the cover with the probe readyto be used;

FIG. 16 shows a UV assisted introducer kit in accordance with anotherembodiment of the invention;

FIG. 17 is a bottom view of the kit of FIG. 16; and

FIG. 18 shows the patient resting an arm on the kit of FIG. 16.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents that operate in similarmanner to accomplish a similar purpose. Several preferred embodiments ofthe invention are described for illustrative purposes, it beingunderstood that the invention may be embodied in other forms notspecifically shown in the drawings.

The catheter of the present invention has several features which willimprove medical treatment. With these added features, the catheter makesIV placement with ultrasound easier, more efficient, and more accurate,thus significantly decreasing pain experienced by the patient byreducing the number of IV sticks currently performed.

As shown in the drawings the invention comprises of multiple elementsthat have separate novel advantages and features, but also can beutilized together to improve medical treatment by making IV placementwith ultrasound easier, more efficient and more accurate, and reducingpain. Those elements include a catheter introduction apparatus (FIGS.1-11B), a UV-visible catheter (FIG. 12), a needle cover with markingmeans (FIG. 11A-11C), a probe cover (FIGS. 13-15), a sterile kit package(FIGS. 16-18), and a catheter having finger tabs (FIGS. 11A, 11B).

The Introducer Apparatus 10 (FIGS. 1-11)

Turning to FIGS. 1-10, an illustrative non-limiting embodiment of theintroduction device or introducer apparatus 10 is shown. As best shownin FIG. 2, the introducer 10 has a housing 100, a controller or wheelassembly 130, drive wire 12, and guide wire 14. The housing 100 isslightly elongated an ergonomically shaped to fit in the palm of auser's hand. The inside of the housing 100 is hollow, such that thehousing 100 forms a wall 104. The housing 100 has a front end 108 and arear end 106. An opening 102 is provided at the rear end 106.

An elongated coupling 114 extends forward from the distal front end 108of the housing 100. The coupling (or coupling post or needle attachment)114 has the shape of an elongated post having a round cross-section. Thecoupling 114 has a central opening. At the front of the coupling 114,the central opening is sized to be slightly larger than the guide wire14. At the middle of the coupling, the opening gets progressively largerto the rear end of the coupling 114. The guide wire 14 has a proximalend with a straight tip. The tapered opening forms guide walls 116 thatfunnel the guide wire toward the smaller portion of the opening so thatthe guide wire 14 can be pushed through the coupling 114 and out of thecoupling 114 without stubbing or damage.

A guide post 110 is also provided at the front end 108 of the housing100. The guide post 110 extends forward from the front end 108. The post110 is elongated, has a square-shaped cross-section (though any suitableshape can be utilized), and extends substantially parallel to andslightly spaced apart from the coupling 114. The post 110 is shorterthan the coupling 114, but creates a channel 112 between the post 110and the coupling 114. An injection needle can then be received over thecoupling 114 and is further secured in the channel 110 by the post 110.There can be a single post 110 positioned above the coupling 114 (FIG.2) or two posts on opposite sides of the coupling 114 (FIG. 1), or botha single post 110 above the coupling and two posts on opposite sides ofthe coupling. It will be apparent that any number of posts 110 can beprovided and positioned anywhere about the coupling 114 to reliablyreceive and retain the injection needle. In addition, other couplingmeans can be provided to reliably couple the needle to the housing 100.

As best shown in FIG. 1, the wheel or guide wheel assembly 130 isprovided in an opening 103 located at the top of the housing 100 at thefront end 108. As more fully shown in FIG. 3, the wheel assembly 130includes a wheel or guide wheel 132, with teeth 134 that extendtransversely along the outer circumferential edge or surface (i.e. outercircumferential guide surface) of the wheel 132. The teeth 134 enablethe user to more easily turn the wheel 132. A small circular post ordrum 136 is provided (i.e. transversely coupled) on one transverse side(i.e. transverse circular side) of the wheel 132 such that the post ordrum 136 is transversely offset from to drum. The circular drum 136having a drum diameter projects outward from the side of the wheel 132and is concentrically aligned with the wheel 132. A through-hole 138defining the wheel axis extends transversely through the center of thedrum 136 and the wheel 132. A pin 140 extends through the through-hole138 and engages openings in the two opposing sides 101 (FIG. 1) of thehousing 100 so that the wheel 132 can rotate about the pin 130. The drum136 is fixed (i.e. fixedly coupled) to the wheel 132 so that the drum136 rotates as the wheel 132 rotates.

Returning to FIG. 2, one end of the drive wire 12 is partly wrappedabout the drum 136. For instance, the distal end of the drive wire 12can be at least partially placed in a hole 137 (FIG. 3) that extends atleast part way through the drum 136 to hold the drive wire 12 in placeon the drum 136. Other suitable coupling methods can be used, such asadhesive, or a fastener. Thus, the user can wind the drive wire 12 toretract the drive wire 12. The drive wire 12 is sufficiently rigid toretain a straight form, but sufficiently flexible to wind about the drum136 of the wheel 132.

Still referring to FIG. 2, a lock assembly 150 is located just behindthe wheel assembly 130 on the housing 100. The lock assembly 150includes a locking tab 152, cover 156, nut 162, bolt 164, and displayarea 158 that can be used to present a logo or directions to the user.The bolt 164 extends through an opening in the housing 100 and anopening in the locking tab 152. The head 160 of the bolt 164 is outsideof the housing 100 and the bolt 164 attaches to a nut 162 located on theopposite side of the locking tab 152. The bolt 164 fastens the tab 152in place on the housing 100 to engage the teeth 134 of the wheel 132.The locking tab 152 is a flat element that extends to the teeth 134 onthe wheel 132. The tab 152 can be somewhat flexible, so that the usercan operate the wheel 132. However, the tab 152 prevents the wheel 132from moving when not be operated on by the user, and in particularprevents the wheel 132 from moving backwards to retract the drive wire12. The tab 152 can also make a clicking noise as the wheel 132 is beingmoved forward, to provide an audible and/or tactile feedback thatconfirms to the user that the wheel 132 is being moved. Though a boltand tab 152 are shown, it will be readily apparent that other mechanismscan be provided to prevent unintended operation of the wheel 132. Forinstance, the wheel 132 can be friction fit into the opening 103 so thata slight force is needed to move the wheel 132. The cover 156 extendsover the bolt head 160 so that the user does not get injured by the bolthead 160. The cover 156 can be adhered or fastened to the housing 100.

A connector or plug 170 is provided at the distal ends of the drive wire12 and the guide wire 14. As best shown in FIG. 4, the connector 170 isconfigured to engage both the drive wire 12 and the guide wire 14 sothat the guide wire 14 moves when the drive wire 12 moves. The connector170 has a connector body 171 that includes a first opening 172 thatreceives the drive wire 12 by a friction fit. The body 171 also has apost 174 that extends forward and has an opening that receives the guidewire 14 by a friction fit. In addition, the body 171 includes a guidepost or guide tab 176 that extends forward substantially parallel to thedrive wire 12. A small channel is formed between the tab 176 and thedrive wire 12 to receive and engage a tube or sheath 15 (FIG. 1) thatsurrounds the two wires 12, 14 to prevent injury to the user or patient.The guide wire 14 is straight inside the sheath 15 and the sheath 15fully encloses the distal end of the guide wire 14. A slit extends theentire longitudinal length of the straight sheath 15, and the guide post176 moves through the slit. This keeps the drive wire 12 and the guidewire 14 properly oriented with respect to each other during operationand so they do not become twisted. Instead of a sheath 15, the housing100 can be extended to cover the two wires 12, 14.

Operation of the introducer 10 will now be discussed with respect toFIGS. 5-9. In these illustrative non-limiting embodiments, theintroducer 10 is coupled with a conventional introducer needle assembly200 having a standard catheter. One example of a suitable needleassembly is offered by Smiths-Medical, JELCO® I.V. Catheter,www.smiths-medical.com. It will be recognized however, that theintroducer 10 can be used with other suitable devices, such as Insyte™Autoguard™ Shielded IV Catheters by Becton Dickinson (www.medline.com),Introcan Safety® IV Catheter Straight by B Braun www.medline.com), IVCatheters by Exel International (www.medline.com), and OPTIVA® IVCatheters by Smiths Medical (www.medline.com).

As shown in FIG. 5, the needle assembly 200 has a round tubular housing204, needle 202, hub 206 and support member 208. The housing 204 has afirst end that is open and mates with the coupling member 114. Thesupport member 208 is fitted at an opposite end of the needle housing204 and the hub 206 is placed about the support member 208. The needle202 extends through openings in the hub 206 and support member 208 andpartly into the front end of the interior of the housing 204. Thecoupling 114 of the introducer assembly 10 aligns the guide wire 14 withthe needle 202 of the needle assembly 200. A catheter 300 extends overthe outside of the needle 202 and terminates at and couples with the hub206.

The operation starts with FIG. 5, where a needle assembly 200 is alignedwith the introducer 10. The drive wire 12 and guide wire 14 are fullyretracted at the rear of the introducer 10. Turning now to FIG. 6, theuser places the needle assembly 200 on the introducer 10. The tubularhousing 204 of the needle assembly 200 is slidably received over thecoupling 114 of the introducer 10. The housing 204 wall enters thechannel(s) 112 between the one or more post(s) 110 and the coupling 114.The needle housing 204 fits snugly about the coupling 114, so that theneedle assembly 200 does not come free of the introducer 10 untiloperated on by the user. As shown, the guide wire 14 is aligned with theneedle 202. It will be appreciated that though this is described as amanual process, the introducer 10 can come pre-loaded with a needleassembly 200 already positioned on the introducer 10. Or the introducer10 can have a needle integrally formed with the introducer 10.

At this point the user places the needle 202 into the patient, such asthe vein or artery lumen. To do so, the needle cover 250 (FIG. 11B) isfirst taken off of the needle and the needle cover tip 252 (FIGS. 11B,11C) is used to mark the skin surface either with pressure or a markingink in two spots to give directional marking for the direction of thecannulation. The needle cover tip 252 has one or more projections 254that extend forward from the front surface of the tip 252. Theprojections 254 shown are concentric curves that form a company logo.However, the projection(s) 254 can have any shape, such as an arrow,line, or dot. Ink can be placed on the projections 254 and applied tothe patient. Or, the projections 254 can be pushed into the patient'sskin without ink, to cause pressure indentations on the patient. Theuser can use the inked cap to place directional markings on the patient.Without this it can be difficult to place cannula once it has enteredunder the skin. This can be especially useful with ultrasound guidance.Both marks are made at points along the vessel. The cannula (also calleda catheter) 300 is placed in the direction of this guidance in line withthe vessel and the needle 202 is inserted into the patient. For deepvessels and small vessels the directional marking is of particularadvantage. To visualize smaller vessels ultrasound can be used. Asfurther shown in FIG. 11B, the needle cover 250 has a main tube thatextends the length of the needle 202, and one or more arms 256 at therear end that extend outward and upward over the top of the hub 206. Thearms 256 protect the hub 206 and make it easy for the user to remove thecover 250. The cover 250 can come pre-assembled over the needle 202, andprotects the user from being injured by the needle 202.

Returning to FIG. 6, after the needle cover 250 is removed, the needleis aligned along the skin with the two points marked for direction andthen inserted into the lumen of the vessel. Once the needle 202 isproper placed, the user turns the wheel 132 forward with an index fingerin the direction X. This operation can be done using a single hand ofthe user. Since the needle 202 is already positioned in the vein, theuser simply rotates the wheel 132, which is easy to reach because it isat the front end 108 of the housing body 100. Thus, the user can retainhold of the housing 100 in the palm of the hand and (without moving hishand) operate the wheel 132 with the index finger. In addition, the userholds the introducer 10 steady (i.e., it does not have to be movedforward) and allows the movement of the wheel 132 to advance the guidewire 12, so that single-handed operation is possible. Single-handedoperation is further made possible by the contour shape of the hub.Thus, the user can hold an ultrasound probe in the other hand to assistplacement of the guide wire 12 and catheter 300. The tab 152 preventsthe wheel 132 from moving in reverse.

As the wheel 132 is moved forward, it draws the drive wire 12 furtheronto and around the wheel drum 136. This, in turn, causes the connector170 to push the guide wire 14 forward (to the left in the embodiment ofFIG. 7). The guide wire 14 enters the central opening in the needle 202and continues through the needle 202 until it emerges from the distaltip of the needle 202 and enters the patient, as shown in FIG. 7.Accordingly, the guide wire 14 threads the vessel lumen.

The thin guide wire 14 is then ready to have the soft plastic catheter300 slid over the guide wire 14 into the vessel lumen. As shown in FIG.8, once the guide wire 14 has entered the user's vein (which is roughlyone to two and a half inches depending on catheter length), the userpushes the hub 206 (or finger tabs on the catheter 300, if used) forwardto force the catheter off the needle 202 and into the patient. Thesupport 208 keeps the needle 202 positioned on the introducer 10. Thecatheter 300 can be pushed into the patient further than the needle 202and/or guide wire 12 since it is more flexible and won't puncture theside of the vein or vessel. The user can then remove the needle 202 andguide wire 12 from the patient, leaving the catheter and hub 206properly placed in the patient, as shown in FIG. 9. The user can thenconnect a syringe, intra venous (IV) device or other medical instrumentat the rear end of the hub 206.

Turning to FIG. 10A, an alternative embodiment of the invention isshown. Here, the needle 202 is an elongated shank portion having abeveled tip. The shank is hollow or cannulated and is joined at its rearor end to a hollow transparent hub 2 having a rounded front end. Thecatheter 300 is sized to be telescopically fitted over the shank of theneedle 202. As with FIGS. 1-9, the catheter 300 is slightly shorter thanthe needle 202 so that when it is fully pushed back against the needlehub 2 the beveled tip 5 of the needle projects outwardly from thecatheter tip 4 by an amount sufficient to permit puncture of the bloodvessel by the user of the device. A female luer-type fitting 9 is formedon the rear of the catheter and mates with and fits over a shoulderprojection 11 on the front of the hub 2. The wire guide assembly 3includes an elongated tubular member 19 which is fitted into the counterbore at the end of hub 2. The tubular member 19 can be formed of atransparent, semi-rigid plastic material, and have sufficient resilienceto maintains its tubular configuration and use. A guidance tab 16interfaces with the hollow, grooved tube 19. The tab 16 is attached tothe back of the guide wire, and slides through the groove, making surethat the wire does not tangle or twist. The shoulder projection 11 is asolid plastic piece that is part of the housing and holds the wheel. Aflash guard 13 keeps blood from spilling or squirting out the back endof the device. A safety cap 18 is also provided that can be removed whenthe device is used.

In its preferred form, the tubular member 19 has a longitudinallyextending slot running from a point adjacent the needle hub 2. A plug orother suitable sealing means provides a seal for the end. An elongatedflexible spring wire guide is housed within tubular member 19. A wheelis provided that directly acts on the spring wire guide to advance thespring wire guide. This can be done, for instance, by a drum or shaftthat is attached to the wheel. The outer surface of the drum can pressthe guide wire between a fixed surface on the housing to physically movethe guide wire forward by friction. The drum can have a outercircumferential drive surface that grabs the guide wire.

A laterally or radially extending handle 7 is fastened to its rear endhandle projects through the slot and is adapted to advance the springwire guide through the lumen through needle and outwardly from thedistal end into and through the lumen of the blood vessel. Forfacilitating this insertion with the use of one hand the index fingerpushes one of the finger tabs on either side of the cannula 4. Once inplace the cannula 4 can be secured with the securing tabs. The securingtabs can be secured to the skin, either with an adhesive tape or suturedinto place through the holes in these tabs.

The tabs 210 are best shown in FIG. 11A. The needle 202 is connected toa hub 206 having a rounded front end. Handles or tabs 212 are connectedto the catheter, and handles or tabs 210 are connected to the hub 206.The catheter handles 212 and the hub handles 210 are elongated andrectangular, and extend outward substantially transverse to the catheter300 and hub 206, respectively. The user can grab the tabs 202 to pushthe catheter 300 forward. And the user can grab the tabs 210 to push thehub 206 forward. Thus, the hub 206 has elongated slots to receive thehub handles 210. The catheter handles 212 and the hub handles 210 areeasier for the user to grab and operate.

As further shown in FIG. 11A, a flash chamber 214 can be provided behindthe hub 206. The flash chamber 214 allows the user to see blood andfluid. Once the vessel is pierced by the needle 202, blood enters theflash chamber 214. The flash chamber 214 is transparent, so that theuser can visually confirm that the vessel has been pierced but to keepthe blood from getting on the practitioner, patient or device. Thechamber 214 has a tab 216 that can connect to a safety cap. In thepresent embodiment, the needle 202 is connected to the flash chamber214, but the flash chamber 214 is not connected with the hub 206. Thecatheter 300 is connected to the hub 206.

Turning to FIG. 10B, an alternative embodiment of the wheel assembly ofFIGS. 1-9 is shown. Here, the wheel assembly 230 has two wheels 232, afirst wheel and a second wheel each having a radius, separated from eachother by a slight gap 233. The first and second wheels 232 each has anouter circumferential edge or surface that can have transverse ridges, aroughened surface or an easy to grip surface (such as rubber), to makeit easy for the user to operate the wheels 232. A circular drum 234 isaffixed to or integral with the side of one of wheels 232. The drum 234has an outer circumferential edge with large transverse ridges or teeth236 positioned thereabout. A locking structure 238 is coupled to thehousing 100 of the introducer 10 and aligned with the drum 234. Thelocking structure 238 has a top inner surface that is aligned with thedrum 234, and can optionally include at least one mating tooth thatengages the drum teeth 236. The drum teeth 236 are configured so thatthe wheel 232 can advance the guide wire 14 into the patient, but thatthe wheel 232 cannot be reversed. The inner surface of the lockingstructure 238 can also rub against the surface of the teeth 236 so thatthe wheel 232 does not move without being operated on by the user. A pin240 extends through the center of the wheels 232 and drum 234 to permitthe wheels 232 and pin 240 to rotate with respect to the housing 100.The drive wire 12 extends into the gap 233 between the wheels 232 andthe end of the drive wire 12 is wrapped about the pin 240. Thus, as theuser operates the wheels 232, the drive wire 12 wraps around the pin 240and advances the guide wire 14 into the patient. The pin 240 canoptionally have a widened portion at the gap 233 to receive the drivewire 12. Or, the two wheels 232 can be connected together as a singlewheel that has a channel which receives the drive wire 12, and the pin240 need not move. It will be apparent that other suitableconfigurations can be provided within the spirit and scope of theinvention.

Usually the wire guide 12 only needs to be fed forward, so the defaultstate of the wire guide feed wheel assembly prevents backward feeding.To prevent backward feeding, the tab 152 (FIG. 2) or gear box 238 (FIG.10B) unidirectional block movement of the drum teeth 236. In order toallow backward feeding of the wire guide, a user can unscrew the bolt164 (FIG. 2) or push down on the wheels 232 (FIG. 10B) and rotate thewheels 232 in the direction opposite of that for forward feeding.Pushing down on the wheels 232 moves the drum 234 away from the gear box238, enabling backward rotation. A spring 23 can maintain the drum teeth236 in contact with the gear box teeth in the default setting.

The entire introducer 10 can be made of a plastic (e.g., medical gradepolymers and UV cure adhesives), except that the tab 152, bolt 164, nut162, drive wire 12 and guide wire 14 are preferably made of metal (suchas stainless steel, 300 series). The entire introducer can be sterilizedand packaged in a sterilized container, such as being heat sealed in aplastic bag. A typical material for the catheter is Tecoflex EG-80Apolyurethane. Component materials are usually a polycarbonate like LexanHP4 or an ABS like Cycolac HMG47MD.

In a non-limiting illustrative embodiment of the invention, the couplingelement 114 is about 1 cm long with a diameter of about 4 mm. Theintroducer 10 is about 6.2 cm long (including the coupling element 114),and has a width of about 3.8 mm. The wheel 132 has a diameter of about1.4 cm. The drive wire 12 has a length of about 20-29 cm, and the guidewire 14 has a length of about 18-27 cm so that the guide wire 14 can beadvanced through the longest needle that is used. The coupling 114 canbe sized to fit any needle, and the guide wire 14 can be sized to anysize needle. Common size needles are 16-18 gauge, but larger gauges suchas 14-15 would be suitable, and still larger or smaller needles may besuitable as well.

The Ultrasound-Guided IV Catheter has a number of features that makeplacement of the catheter in deep peripheral vessels easier. First, ithas an inked cap that permits the user to mark the location anddirection of the vessel as visualized by the ultrasound machine. Thisgives directional guidance to the catheter along the vessel forinsertion. The cap can mark the skin for directional guidance. Whenplacing an ultrasound guided IV catheter the medical professionalplacing that catheter can get lost as to the direction of the needle inrelationship to the vessel. The Ultrasound gives a two dimensional imagewhich does not show direction. The cap on the ultrasound guided IV marksthe surface of the skin so the direction of the vessel can be marked onthe skin. For instance, the marking can have an ink spot or directionalarrow indention into the skin, allowing the catheter to be aligned tothe vessel. The medical professional can then align the needle/catheterwhich the markings and not miss the vessel.

Second, the catheter has a slender guide-wire that can easily threadsmaller, deeper vessels. The guide-wire can easily thread deep vesselsand advance the catheter without catching on the vessel walls. Theultrasound is used to find deeper vessels which cannot be visualized bythe human eye. These deep vessels are difficult to thread with the softlarge plastic catheters. The catheter can catch on the sides of thevessel and thus not slide easily into the lumen of the vessel. TheUltrasound guided IV catheter uses a thin guide wire to thread deepvessels. The guide-wire is placed within the lumen of the vessel firstand then the catheter is threaded over the catheter, preventing thecatheter from getting caught on the sides of the vessel wall.

The guide-wire and catheter can be advanced and placed with only onehand so that as one holds the catheter with one hand the other handholds the ultrasound and visualizes correct entry into the vessel. Thedrive wheel advances the guide wire 14, and the catheter tabs or hubadvance catheter over the guide-wire. The other hand is free tomanipulate the ultrasound. When moving the guide-wire into the vessel atraditional catheter needs two hands for guide-wire placement: one handplacing the catheter and the other hand advancing the guide wire. TheUltrasound guided IV catheter advances the guide-wire and catheter withthe same hand. This gives a unique advantage to ultrasound guidancebecause one person can use his spare hand to hold the ultrasound tovisualize the guide-wire and catheter being advance ensuring placementin the vessel lumen.

The present introducer avoids potential complications with exposure toblood and fluid, and provides a tactile resistance. The drive wire alsoprovides a spring-like behavior when wound about the wheel assembly toprovide greater control of the advancement and retraction of the drivewire. However, it will be apparent that other configurations of theintroducer may be possible within the spirit and scope of the invention.For instance, the drive wire can be eliminated and the guide wiredirectly connected to the wheel assembly to push the guide wire.

The Visible Catheter 300 (FIGS. 11-12)

Another object of the invention is to provide a catheter, both centraland peripheral, that can be visualized by ultrasound, to enable correctplacement to be determined and recorded by ultrasound visualization.Catheters, both central and peripheral, which are easily visualized byultrasound, enable correct placement to be determined and recorded byultrasound visualization.

It is noted that current catheter materials cannot be detected byultrasound. In the present embodiment of the invention, the catheter 300is constructed of materials that can be easily visualized underultrasound. For instance metals, ceramics, or compounds (like bariumsulfate or titanium), can be integrated within the structure of thecatheter material allowing for direct visualization of catheterplacement with the ultrasound. As an example, one could confirm byultrasound that a catheter intended to be placed in a vein is in factlocated in a vein and not in an artery or outside any blood vessel.

Ultrasound properties are material dependent. The sound velocities andimpedance values of typical catheter materials such as plastics,urethanes or rubbers are very low (0.959-2.06 km/s and 1.41-2.00 MRayl)compared to metals such as, aluminum, copper and Titanium (5.01-6.3 km/sand 17.0-44.6 Mrayl). The properties for low density polyethylene andTitanium are compared in FIG. 12. This demonstrates that as the densityof a material changes, so do it's acoustic properties. Materials ofdifferent densities will appear as distinct and different in anultrasound image.

In yet another embodiment of the invention, the outer surface 304 of thecatheter is coated with metallic material such as Titanium, thecatheter. This makes the catheter 300 detectable by ultrasound, becausethe high impedance surface will reflect some of the sound. A specificlength of the catheter to be detected by ultrasound is coated with ametallic coating, such as by using sputtering. Thus, only a portion (thefront end) of the catheter 300 can be coated or made of UV visiblematerials. Sputtering is a Physical Vapor Deposition vacuum process usedto deposit very thin films onto a substrate for a wide variety ofcommercial and scientific purposes. Sputtering occurs when an ionizedgas molecule is used to displace atoms of a specific material. Theseatoms then bond at the atomic level to a substrate and create a thinfilm. Several types of sputtering can be used, including: ion beam,diode, and magnetron sputtering. Sputtering units are availablecommercially and not only they can help in coating a variety of metallicmaterials, but the thickness of the coating can also be measured duringthe sputtering process. The coating thickness is typically in Angstroms.Preferably, Titanium is used best mode, because of its biocompatibilityand excellent corrosion resistance to a broad range of possiblecorroding media that may be encountered in the field of medicine.

It is noted that the catheter 300 and the introducer 10 (FIGS. 1-10) ofthe invention have separate utility and need not be utilized together.For instance, the catheter 300 can be utilized with any catheterintroduction set, and not only the introducer 10 of the presentinvention. In addition, the introducer 10 can be used to place anyconventional catheter, and need not be utilized with the catheter 300 ofthe present invention. Notwithstanding those separate uses, the catheter300 and introducer 10 of the invention have certain advantages whenutilized together (FIGS. 1-10). Because the catheter 300 is visible toUV detection and the introducer 10 allows the user to perform IVinsertion with a single hand, the user can perform UV detection at thesame time he/she is inserting an IV into the patient. Thus, the user canconfirm proper placement of the needle 202, as well as the catheter 300,during and immediately after insertion. The user can perform thecatheter 300 placement with a single hand using the introducer 10, andwith the other hand can track placement of the needle 202 and thecatheter 300 in the patient.

Probe Cover 400

Another embodiment of the invention is shown in FIGS. 13-15. A sterilecover set 400 is provided that can be placed over the transducer end ofa piece of medical equipment, such as an ultrasound probe 402. Thesterile probe cover set 400 includes a sterile probe cover 404 and acontainer 410. The cover 404 is open at the top (i.e., no lid or cover)and can be made of rubber or latex for instance, can have the generalshape of the probe 402 and is sized to fit snugly over the probe 402. Inthe embodiment shown, the cover 404 is shaped like a bag, with a bottomand sides and can optionally match the shape of the probe end 401. Thecontainer 410 can have a similar shape as the cover 404 and is slightlywider than the cover 404. The container 410 is shorter than the cover404 so that the tops 406 of the sides extend beyond the top of the sidesof the container 410. In the current embodiment, the container 410 canbe a circular piece, with a bottom and sides, or can be a tube with nobottom, or can have a rectangular shape. The container 410 canoptionally match the shape of the probe end 401. The container 410 canbe made of cardboard or from hard plastic or other material which canmaintain its shape and the shape of the rubber sterile probe cover 404.The container 410 is wider than the probe and the cover 404, so that thecover 404 is stretched and can be easily fit over the end 401 of theprobe 402.

The cover 404 is pre-assembled to be inside the container 410, and thetop sides 406 of the cover 404 are stretched and folded down over thetop sides of the container 410. The container 410 and cover 404 arepackaged in a sealed plastic bag, and the entire packaging issterilized.

When the probe 402 is ready to be used, the user opens the sealedplastic bag and removes the container 410 with the cover 404 positionedinside of the container 410. The user should preferably hold theassembly by the container 410. However, only the inside of the cover 404is exposed (since the cover is turned inside-out at the top sides 406),so the user can touch the cover 404 without contaminating the outside ofthe cover 404.

As shown in FIG. 13, the user then pushes the container 410 and cover404 over the end of the probe 402, so that the sterile probe cover 404is wrapped around the probe 402. Optionally, ultrasound gel can beplaced on the surface of the sterile probe cover prior to placing it onthe ultrasound probe. Referring to FIG. 14, the cover 404 and container410 are positioned over the probe 402. The top sides 406 of the cover404 are then folded up, off of the container 410 and onto the probe 410.Because the top sides 406 were stretched to fit over the container 410,the top sides 406 will retract inward and form a snug fit on the probeend 401. At this point, the cover 404 is on the probe 402. Referring toFIG. 15, the container 410 is then removed from the probe 402, leavingthe sterile probe cover 404 on the probe transducer end 402. During theprocess, the sterile probe cover remains sterile, because the operatoronly touches the container 410. The sterile probe cover 404 is nevertouched by the operator.

It should be appreciated that the assembly 400 can be preassembled sothat the top portion 406 is folded downward over the top of thecontainer 410. The cover 404 may need to be stretched in order to do so,and so that the cover 404 fits the probe. In accordance with oneembodiment of the invention, the probe cover is less than 3 inches deep,4 inches in width and 4 inches in height. It will be appreciated thatwhile a snug fitting cover 404 is provided in the current embodiment, alonger and looser fitting cover 404 can be provided that is secured tothe probe 402 by rubber bands or the like.

The Ultrasound Introducer Kit

One object of the invention is to provide a catheter introduction setthat is particularly well suited for use with a single hand. Thecatheter introduction set includes a proximal end and a distal end, withthe proximal end able to couple with a needle. The introducer device caneither come packaged and mated with a catheter and introducer needle, orbe mated by the user with another prepackaged needle. To enablesingle-handed use, the means to control the guide-wire is located withinthe proximal two-thirds of the catheter introduction set. An additionalinventive step enabling single-handed use is the introduction of cannulaprogression means that are located within the proximal two-thirds of thecatheter introduction set.

Turning to FIGS. 16-18, another embodiment of the invention is shown.Here, an introducer kit 500 is provided. The kit 500 includes a case orbox 501 having a base 502 and a lid or top 504. The box 501 isrectangular in shape and the top 504 is larger than the base 502 so thatit is easy to remove the top 504. As best shown in FIG. 17, the box alsohas a bottom 506. A pad 508 is provided at the exterior surface of thebottom 506. The pad 508 can be at a portion of the bottom 506 or extendthe entire width and height of the bottom 506. Referring to FIG. 18, thepatient can rest his/her arm on the pad 508 during IV placement or othermedical procedure. The pad 508 stabilizes a body part that is to becatheterized. In the embodiment shown, the pad 508 of the kit case 500stabilizes the patient's arm at the elbow to assist in catheterizationof the anti-cubital veins. In an alternative embodiment of theinvention, the bottom 506 can have a concave shape instead of a pad 508.

The box 501 has an interior space that is used to retain medicalequipment that is useful for a medical practitioner to perform a medicalprocess, in particular an ultrasound assisted vessel cannulation. Thus,the kit 500 includes all the single-use components necessary forultrasound assisted vessel cannulation, including: catheter introducer10 (FIGS. 1-10); catheter tubing 300 (FIG. 11); probe cover set 400(FIGS. 13-15); lidocaine solution; sterilizing solution and applicator;suture material; suturing needle; gauze pads; scalpel; drape withadhesive; towel; sterile US gel packet; two rubber bands; directionalmarker; normal saline flush; and tourniquet. It will be appreciated,however, that the kit 500 need not include every single element listedhere, and still be within the spirit and scope of the invention. Inparticular, the introducer 10, catheter tubing 300, and probe cover set400 of the invention need not be provided with the kit 500, and anyconventional introducer, catheter tubing and probe cover can beprovided. The box 501 and its contents can be placed in a heat-sealedplastic bag and sterilized.

For use in vessel cannulation, the patient is first placed in arecumbent position. After the contents are removed from the sterilepackage the box 501 is flipped so that the ergonomically designed bottomfaces up and the elbow is placed on this surface to facilitatestabilization for cannulation. The kit keeps all necessary materialslocated in a single convenience place in a sterile manner. The box 501provides arm stabilization for safe and successful cannulation.

The foregoing description and drawings should be considered asillustrative only of the principles of the invention. The invention maybe configured in a variety of shapes and sizes and is not intended to belimited by the preferred embodiment. Numerous applications of theinvention will readily occur to those skilled in the art. Therefore, itis not desired to limit the invention to the specific examples disclosedor the exact construction and operation shown and described. Rather, allsuitable modifications and equivalents may be resorted to, fallingwithin the scope of the invention.

The invention claimed is:
 1. A wire introduction device for introducinga guide wire into a body of a patient, the device comprising: a guidewire having a front end and a rear end; a housing body having a frontend with a front opening and a rear end with a rear opening, wherein thehousing body is configured so that the rear end of the guide wireextends outward from the rear end of the housing body through the rearopening; a needle attachment at the front end of the housing body aboutsaid front opening, the needle attachment having an outer surfaceconfigured to receive a needle assembly having a needle to couple thehousing body with the needle assembly; a transparent straight elongatedtubular sheath coupled at the rear end of said housing body, saidtubular sheath forming an enclosure with the housing body that surroundsthe entire guide wire that extends outside the rear end of said housingbody, whereby the guide wire is straight from the rear end of the guidewire to the rear end of the housing; a guide wheel rotatably coupledwith said housing body, said guide wheel having an outer circumferentialguide surface that is operated by a user and a transverse circular side,wherein the outer circumferential guide surface does not directlycontact the guide wire; a circular drum positioned on the transversecircular side of said guide wheel and having an outer circumferentialdrive surface positioned on and touching a first side of the guide wire;and a fixed surface on the housing positioned on a transversely oppositeside of the guide wire from the circular drum, whereby the outercircumferential drive surface of the circular drum and the fixed surfaceon the housing cooperate to advance the guide wire with respect to thehousing body through the front opening and the needle attachment andinto the patient body upon rotation of the guide wheel towards the rearopening of the housing body.
 2. The wire introduction device of claim 1,wherein the drum is fixedly coupled to the guide wheel.
 3. The wireintroduction device of claim 1, wherein the device is configured forsingle-handed operation using a finger of the hand.
 4. The wireintroduction device of claim 1, wherein no part of the outercircumferential guide surface of the guide wheel contacts any surface ofany component of the wire introduction device.
 5. The wire introductiondevice of claim 1, wherein the rear end of the guide wire comprises astraight tip.
 6. The wire introduction device of claim 1, wherein theguide wheel is a first wheel of a wheel assembly, wherein the wheelassembly further comprises a second wheel contacting a second side ofthe circular drum opposite the first wheel and sharing the same wheelaxis as that of the first wheel, and wherein the second wheel ispositioned partially inside the housing body and partially outside ofthe housing body extending through the wheel opening.
 7. The wireintroduction device of claim 6, wherein the circular drum is fixedlycoupled to both the first and second wheels.